FDA Adverse Event Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 3952127 · Received July 23, 2014

Report

Report Number
1531186-2014-02694
Date Received
July 23, 2014
Report Date
June 11, 2014
Manufacturer
C.T.M. TAIWAN
Product Code
INI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

DEALER STATED THAT THE COMET4-B SCOOTER KEEPS SPEEDING UP AND SLOWING DOWN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
431484 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. TAIWAN COMET4-B

Patients

Seq Age Sex Outcome Treatment
1 Other